Dataset Information

Impact of Motivational Interviewing on Self-Management in Patients With Type 2 Diabetes: Protocol for a Pilot Randomized Controlled Trial.

ABSTRACT:

Background

The nonpharmacological approach to diabetic control in patients with diabetes focuses on a healthy diet, physical activity, and self-management. Therefore, to help patients change their habits, it is essential to identify the most effective approach. Many efforts have been devoted to explain changes in or adherence to specific health behaviors. Such efforts have resulted in the development of theories that have been applied in prevention campaigns and include brief advice and counseling services. Within this context, motivational interviewing (MI) has proven to be effective in changing health behaviors for specific cases. However, stronger evidence is needed on the effectiveness of MI in treating chronic pathologies such as diabetes.

Objective

This study will obtain preliminary data on the impact of a nurse-led MI intervention in improving glycemic control, as well as clinical, psychosocial, and self-care outcomes for individuals with type 2 diabetes mellitus when compared with usual care, with the aim of improving diabetic control in patients with diabetes.

Methods

An open, two-arm, parallel, randomized controlled, pilot exploratory trial will be performed. Two government outpatient clinics in the New Territories West Cluster in Hong Kong will be involved. In total, 20 to 25 participants will be invited in each arm. Intervention participants will receive face-to-face MI interventions in addition to their usual care from the clinic. Control participants will only receive usual care. Outcomes are assessed at baseline, 6 months, and 12 months. The primary outcome measure is glycated hemoglobin levels. Secondary outcomes include blood pressure, BMI, hip and waist circumference, fasting blood, and psychosocial and self-care measures.

Results

This study is currently underway with funding support from the Hong Kong College of Family Physician Research Seed Fund 2017.

Conclusions

MI skills constitute the main strategies primary care nurses use on their patients. Having economical, simple, effective, and applicable techniques is essential for primary care professionals to help their patients change their lifestyle and improve their health. This study will provide scientific evidence on the effectiveness of MI. It will be performed with strict control over the data collection, ensuring the maintenance of therapeutic integrity.

Trial registration

Centre for Clinical Research and Biostatistics CUHK_CCRB00614; https://tinyurl.com/v9awzk6.

International registered report identifier (irrid)

DERR1-10.2196/15709.

SUBMITTER: Wong MK

PROVIDER: S-EPMC7157490 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Impact of Motivational Interviewing on Self-Management in Patients With Type 2 Diabetes: Protocol for a Pilot Randomized Controlled Trial.

Wong Man Kin MK Cheng Sai Yip Ronald SYR Chu Tsun Kit TK Lam Fung Yee FY Lai Shiu Kee SK Wong Kai Chung KC Liang Jun J

JMIR research protocols 20200331 3

<h4>Background</h4>The nonpharmacological approach to diabetic control in patients with diabetes focuses on a healthy diet, physical activity, and self-management. Therefore, to help patients change their habits, it is essential to identify the most effective approach. Many efforts have been devoted to explain changes in or adherence to specific health behaviors. Such efforts have resulted in the development of theories that have been applied in prevention campaigns and include brief advice and ...[more]

PMID: 32229475

Similar Datasets

Project description:BackgroundHeart failure (HF) is characterized by an increasing prevalence, representing a public health problem and a significant cause of morbidity and mortality. Self-care is a cornerstone approach for optimizing therapy for patients with HF. Patients play a crucial role in managing their condition, given that several adverse health outcomes might be avoided with adequate self-care. In this regard, the literature describes motivational interviewing (MI) as highly favorable for treating chronic diseases, with promising results supporting its efficacy in enhancing self-care. Moreover, caregivers' availability constitutes a fundamental supporting factor among the strategies to improve self-care behaviors in people with HF.ObjectiveThe primary study aim is to test the efficacy of a structured program, including scheduled MI interventions, in improving self-care maintenance in the 3-month follow-up from the enrollment. Secondary aims comprehend the assessment of the effectiveness of the above intervention on secondary outcomes (eg, self-care monitoring, quality of life, sleep disturbance) and the corroboration of the superiority of caregivers' participation to the intervention over the program administrated only to individual patients in enhancing self-care behaviors and other outcomes at 3, 6, 9, and 12 months from the enrollment.MethodsThis study protocol designed a prospective, parallel-arm, open-label, 3-arm, controlled trial. The MI intervention will be administered by nurses trained in HF self-care and MI; the education program will be provided to nurses by an expert psychologist. Analyses will be performed within the framework of intention-to-treat analysis. Comparisons between groups will be based on an alpha of 5% and 2-tailed null hypotheses. In the case of missingness, analyzing the extent of the missingness and identifying underlying mechanisms and patterns will guide imputation methods.ResultsThe data collection was started in May 2017. We completed the data collection with the last follow-up in May 2021. We plan to perform data analysis by December 2022. We plan to publish the study results within March 2023.ConclusionsMI enhances potential self-care practices in patients with HF and their caregivers. Although MI is effectively largely employed either alone or combined with other treatments and is administered in different settings and ways, face-to-face interventions seem to be more effective. Dyads with higher shared HF knowledge are more efficient in promoting self-care adherence behaviors. Moreover, patients and caregivers may perceive proximity with health care professionals, resulting in a better ability to follow the received health professionals' directions. The scheduled in-person meetings with patients and caregivers will be exploited to administer MI, respecting all the safety regulations for infection containment. The conduction of this study may support changes in clinical practice to include MI to improve self-care for patients with HF.Trial registrationClinicalTrials.gov NCT05595655; https://clinicaltrials.gov/ct2/show/NCT05595655.International registered report identifier (irrid)DERR1-10.2196/44629.

Project description:BackgroundRelaxation, biofeedback, and cognitive behavioral therapy are evidence-based behavioral therapies for migraine. Despite such efficacy, research shows that only about half of patients initiate behavioral therapy recommended by their headache specialists.ObjectiveMotivational interviewing (MI) is a widely used method to help patients explore and overcome ambivalence to enact positive life changes. We tested the hypothesis that telephone-based MI would improve initiation, scheduling, and attending behavioral therapy for migraine.MethodsSingle-blind randomized controlled trial comparing telephone-based MI to treatment as usual (TAU). Participants were recruited during their appointments with headache specialists at two sites of a New York City medical center.Inclusion criteriaages from 16 to 80, migraine diagnosis by United Council of Neurologic Subspecialty fellowship trained and/or certified headache specialist, and referral for behavioral therapy for prevention in the appointment of recruitment.Exclusion criteriahaving done behavioral therapy for migraine in the past year. Participants in the MI group received up to 5 MI calls. TAU participants were called after 3 months for general follow-up data. The prespecified primary outcome was scheduling a behavioral therapy appointment, and secondary outcomes were initiating and attending a behavioral therapy appointment.Results76 patients were enrolled and randomized (MI = 36, TAU = 40). At baseline, the mean number of headache days was 12.0 ± 9.0. Self-reported anxiety was present for 36/52 (69.2%) and depression for 30/52 (57.7%). Follow-up assessments were completed for 77.6% (59/76, MI = 32, TAU = 27). The mean number of MI calls per participant was 2.69 ± 1.56 [0 to 5]. There was a greater likelihood of those in the MI group to initiating an appointment (22/32, 68.8% vs 11/27, 40.7%, P = .0309). There were no differences in appointment scheduling or attendance. Reasons stated for not initiating behavioral therapy were lack of time, lack of insurance/funding, prioritizing other treatments, and travel plans.ConclusionsBrief telephone-based MI may improve rates of initiation of behavioral therapy for migraine, but other barriers appear to lessen the impact on scheduling and attending behavioral therapy appointments.

Project description:BACKGROUND:The present study protocol is designed to cover the Norwegian part of the European Union Collaborative Project-REgioNs of Europe WorkINg together for HEALTH (RENEWING HEALTH). Self-management support is an important element of care for persons with type 2 diabetes (T2D) for achieving metabolic control and positive lifestyle changes. Telemedicine (TM) with or without health counseling may become an important technological aid for self-management and may provide a user-centered model of care. In spite of many earlier studies on TM, there remains a lack of consensus in research findings about the effect of TM interventions. OBJECTIVE:The aim of RENEWING HEALTH is to validate and evaluate innovative TM tools on a large scale through a common evaluation, making it easier for decision makers to choose the most efficient and cost-effective technological interventions. The Norwegian pilot study evaluates whether the introduction of a mobile phone with a diabetes diary application together with health counseling intervention produces benefits in terms of the desired outcomes, as reflected in the hemoglobin A1c level, health-related quality of life, behavior change, and cost-effectiveness. METHODS:The present study has a mixed-method design comprising a three-armed prospective randomized controlled trial and qualitative interviews with study data collected at three time points: baseline, after 4 months, and after 1 year. The patients' registrations on the application are recorded continuously and are sent securely to a server. RESULTS:The inclusion of patients started in March 2011, and 100% of the planned sample size is included (N=151). Of all the participants, 26/151 patients (17.2%) are lost to follow-up by now, and 11/151 patients (7.3%) are still in the trial. Results of the study protocol will be presented in 2014. CONCLUSIONS:The key goals of this trial are to investigate the effect of an electronic diabetes diary app with and without health counseling, and to determine whether health counseling is important to the continued use of the application and the patients' health competence and acceptability. Research within this area is needed because few studies have investigated the effectiveness of apps used in long-term interventions with this degree of self-management. TRIAL REGISTRATION:Clinicaltrials.gov NCT01315756; http://clinicaltrials.gov/ct2/show/NCT01315756 (Archived by WebCite at http://www.webcitation/6BTyuRMpH).

Project description:BackgroundObesity is a chronic disease and is an established risk factor for other chronic diseases and mortality. Young adulthood is a period when people may be highly amenable to healthy behavior change, develop lifelong healthy behaviors, and when primary prevention of obesity may be feasible. Interventions in early adulthood have the potential for primary or primordial prevention (i.e., preventing risk factors before disease onset). The primary objective of this study is to determine the feasibility of a 6-month behavioral and educational intervention to promote healthy behaviors for obesity prevention among young adults.MethodsThis is the study protocol for a pilot randomized controlled trial. Young adults (age 18-29) attending McMaster University, Hamilton, Canada, will be recruited and randomized to either the intervention or control. The intervention will include individual motivational interviewing sessions (online or in-person) with a trained interviewer plus educational materials (based on Canada's food guide and physical activity recommendations). The control group will receive educational materials only. The primary feasibility outcomes that will be evaluated as part of this pilot study include enrollment, retention (≥ 80%), data completion (≥ 80% of weights measured, and surveys completed), and participant satisfaction. Secondary clinical outcomes will include body mass index (BMI) change from baseline to 6 months, physical activity, nutrition risk, health-related quality of life mental health, and economic outcomes. Outcomes will be measured remotely using activity trackers, and online questionnaires at baseline and every 2 months. Risk stratification will be applied at baseline to identify participants at high risk of obesity (e.g., due to family or personal history). Exit questionnaires will collect data on how participants felt about the study and cost analysis will be conducted.DiscussionOur pilot randomized controlled trial will evaluate the feasibility of an obesity prevention intervention in early adulthood and will inform future larger studies for obesity prevention. The results of this study have the potential to directly contribute to the primary prevention of several types of cancer by testing an intervention that could be scalable to public health, post-secondary education, or primary care settings.Trial registrationhttps://clinicaltrials.gov/ct2/show/NCT05264740 . Registered on March 3, 2022.

Dataset Information

Impact of Motivational Interviewing on Self-Management in Patients With Type 2 Diabetes: Protocol for a Pilot Randomized Controlled Trial.

Background

Objective

Methods

Results

Conclusions

Trial registration

International registered report identifier (irrid)

Publications

Impact of Motivational Interviewing on Self-Management in Patients With Type 2 Diabetes: Protocol for a Pilot Randomized Controlled Trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets